Clinical trial · Interventional
Feasibility of Semi-Permanent Tattoo for Treatment Alignment in Radiation Therapy
NCT05248009CI-TRIAL-00082546completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Consenting subjects will receive a semi-permanent tattoo in place of the standard of care permanent tattoo for radiation marking at the time of the radiation planning scan. Subjects will be monitored to ensure alignment is the same with the semi-permanent tattoo as the current standard of care. Subjects will be monitored to ensure there are no skin reactions or other side effects. Subjects will be followed for 15 months and will send pictures to the treatment team to ensure that the tattoo fades away within 12 months as expected.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
| Tattoo; Pigmentation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Semi-Permanent Tattoo Ink | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Semi-Permanent Tattoo Ink
- description
- Semi-Permanent Tattoo Ink
- interventionNames
- Device: Semi-Permanent Tattoo Ink
Primary outcomes (1)
- measure
- Skin Adverse Events - During Treatment
- timeFrame
- Subjects will be followed weekly during their treatment course
- description
- Adverse events related to the tattooing process including skin toxicity during the completion of radiation therapy will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5). The type, incidence, severity, timing, serious, and relatedness of AE and laboratory abnormalities will be reported and tabulated. The CTCAE is assessed according to grades 1-5, where grade 5 constitutes the highest severity and worse outcome.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients requiring medical tattoo for treatment alignment. * Patient being treated with some form of image guidance including kV, MV, or cone-beam CT. * Age ≥ 18. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be willing to have photos taken of their tattoos through the treatment and follow-up process and may be required to take pictures of their own tattoo to submit to the research team. * Patient able to send picture of tattoo via secure messaging. Exclusion Criteria: * Known allergies or hypersensitivity to tattoo ink. * Personal or religious objection to medical tattooing. * Autoimmune or skin disorders which may be worsened by medical tattooing. * Inability to complete the required forms; however, verbal completion is adequate if recorded on the consent documents.
References
Publications (4)
- BACKGROUNDBryant AK, Banegas MP, Martinez ME, Mell LK, Murphy JD. Trends in Radiation Therapy among Cancer Survivors in the United States, 2000-2030. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):963-970. doi: 10.1158/1055-9965.EPI-16-1023. Epub 2017 Jan 17. PMID 28096199
- BACKGROUNDBregnhoj A, Haedersdal M. Q-switched YAG laser vs. punch biopsy excision for iatrogenic radiation tattoo markers--a randomized controlled trial. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1183-6. doi: 10.1111/j.1468-3083.2010.03617.x. PMID 20236380
- BACKGROUNDWurstbauer K, Sedlmayer F, Kogelnik HD. Skin markings in external radiotherapy by temporary tattooing with henna: improvement of accuracy and increased patient comfort. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):179-81. doi: 10.1016/s0360-3016(01)01439-0. PMID 11316562
- BACKGROUNDJimenez RB, Batin E, Giantsoudi D, Hazeltine W, Bertolino K, Ho AY, MacDonald SM, Taghian AG, Gierga DP. Tattoo free setup for partial breast irradiation: A feasibility study. J Appl Clin Med Phys. 2019 Apr;20(4):45-50. doi: 10.1002/acm2.12557. PMID 30945803